Effect of a High-Protein Diet and β-Hydroxy-β-Methylbutyrate Supplementation in Comparison to a Normo-protein Diet on Muscle Mass, Strength, and Physical Function in Patients With Heart Failure: Protocol of a Three-Arm, Parallel-Group, Superiority Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Change from Baseline in Muscle Mass
研究概览
简要总结
The goal of this clinical trial is to evaluate the effects of a high-protein diet with or without HMB supplementation compared with a normoprotein diet on clinical, nutritional, and functional outcomes in patients with heart failure. The main questions it aims to answer are:
- Does a normocaloric high-protein diet improve muscle mass, muscle strength, and physical function compared with a normocaloric normoprotein diet after 8 weeks?
- Does adding 3 g/day of β-hydroxy-β-methylbutyrate (HMB) to a normocaloric high-protein diet provide additional benefits for muscle mass, muscle strength, and physical function compared with a normocaloric high-protein diet alone?
- Do these nutritional interventions improve renal function, inflammatory and clinical biomarkers, functional status, and quality of life after 8 weeks?
Researchers will compare three groups (normocaloric normoprotein diet, normocaloric high-protein diet, and normocaloric high-protein diet plus HMB supplementation) to determine the effects of these interventions on clinical, nutritional, and functional outcomes.
Participants will:
- Be randomly assigned to one of the three study groups
- Receive individualized dietary counseling according to their assigned intervention
- Receive one study sachet daily containing either an HMB-enriched nutritional supplement (providing 3 g/day of HMB) or a matched placebo, according to the assigned study group
- Undergo assessments of muscle mass, muscle strength, physical function, renal function, inflammatory and clinical biomarkers, and quality of life at baseline, 4 weeks, and 8 weeks
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will not be explicitly informed of the prescribed dietary protein target and will remain blinded to the HMB versus placebo supplementation. Investigators responsible for prescribing the diet cannot be blinded to the dietary intervention but will remain blinded to the supplementation allocation. Outcome assessors and data analysts will also remain blinded to supplementation allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older;
- •Male or female;
- •Diagnosis of chronic heart failure for at least 3 months, established according to the Brazilian Guidelines for Chronic and Acute Heart Failure and confirmed by medical records.
排除标准
- •Chronic kidney disease stage 3b or higher;
- •Listed for heart transplantation;
- •Hospitalization for decompensated heart failure within the previous 3 months;
- •Active cancer treatment or cancer treatment within the previous 5 years;
- •History of alcohol or illicit drug abuse within the previous 12 months;
- •Chronic use of anti-inflammatory drugs, anticonvulsants, corticosteroids, or immunosuppressive agents;
- •Pregnancy or breastfeeding;
- •Wheelchair use preventing anthropometric assessment;
- •Current use of protein supplements;
- •Participation in another randomized clinical trial with interventions that may interfere with the primary outcome.
结局指标
主要结局
Change from Baseline in Muscle Mass
时间窗: Baseline, Week 4, and Week 8
Muscle mass will be assessed using complementary anthropometric measurements, bioelectrical impedance analysis (BIA), and muscle ultrasound. Anthropometric assessment will include mid-upper arm circumference, mid-arm muscle circumference, calf circumference, and adductor pollicis muscle thickness. BIA will be used to estimate skeletal muscle mass and skeletal muscle index (SMI). Muscle ultrasound will assess quadriceps muscle thickness, cross-sectional area, echogenicity, pennation angle, and fascicle length. All measurements will be performed by trained assessors using standardized procedures, and established sex-specific cutoffs will be used to classify reduced muscle mass when applicable.
次要结局
- Change from Baseline in Muscle strength(Baseline, Week 4, and Week 8)
- Change from Baseline in Physical function(Baseline, Week 4, and Week 8)
- Change from Baseline in Renal function(Baseline and Week 8)
- Change from Baseline in High-Sensitivity C-Reactive Protein(Baseline and Week 8)
- Change from Baseline in New York Heart Association (NYHA) Functional Class(Baseline and Week 8)
- Change from Baseline in B-Type Natriuretic Peptide (BNP)(Baseline and Week 8)
- Change from Baseline in Minnesota Living with Heart Failure Questionnaire (MLHFQ) Total Score(Baseline and Week 8)